A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT03884491
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
This study investigates formulations of vortioxetine applied under the tongue
- Detailed Description
Apart from the first two doses, the study design is flexible in terms of doses and pharmaceutical formulations and will be decided upon based on an evaluation of the safety and tolerability as well as plasma exposure obtained during the study.
* The study consists of 5 periods. Single-doses of vortioxetine will be administered in all periods.
* All subjects will receive the same pharmaceutical formulations of the same dose strength in the same period and sequence.
* In Period 1, each subject will receive an intravenous (IV) 10 mg dose of vortioxetine infused over 2 hours. The exposure obtained after IV administration will serve as the reference for the sublingually administered dosage forms.
* In Period 2, each subject will receive 5 mg of formulation A (SLA) of vortioxetine in a sublingual (SL) formulation with a holding time of 90 seconds. The holding time is the time where swallowing of saliva should be avoided.
* For the 3 remaining dosing periods, one or more of the following options in pharmaceutical formulation, dose, and dosing condition apply to this study:
* Increases or decreases in dose (≤25mg) using same formulation
* Change from formulation SLA to formulation SLB
* Change in the holding time
* Change to formulation SLC
* Change in swallowing technique of the sublingual dosage forms
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
-The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit.
-The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Vortioxetine Vortioxetine SLB - Vortioxetine Vortioxetine IV - Vortioxetine Vortioxetine SLC - Vortioxetine Vortioxetine SLA -
- Primary Outcome Measures
Name Time Method absolute bioavailability (F) From predose to 72 hours post dose absolute bioavailability of vortioxetine for the sublingual administrations
tmax From predose to 72 hours post dose time to maximum plasma concentration (tmax)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Sciences Ltd
🇬🇧Nottingham, United Kingdom